CASE STUDY
Top 15 Pharmaceutical Company Selects elluminate to Support Digital Clinical Initiative Background The Clinical Development organization and IT business partners of a large pharmaceutical company are developing a next generation clinical data architecture. The overall goal of the platform is to support the digital health objectives of the business which include identifying promising targets faster, accelerating and advancing clinical trials and developing new evidence-based models that demonstrate value of developed products. The project is being sponsored by executive R&D and IT leadership with key stakeholders from global clinical operations, clinical programming, data management and IT and includes a systems integrator that is helping to define and implement all pieces of the new architecture. The primary objective of the new architecture is to deliver an integrated clinical data platform that will streamline access to clinical data to deliver better insights and improve data driven decision-making for use by clinical operations, data management and clinical programming.
CLIENT BACKGROUND Client: Top 15 Large Pharmaceutical Company
Solution: elluminate for an Integrated Clinical Data Platform
Project Components The new architecture includes the following components: • Metadata Repository & Standards Management Manage data standards across all phases of research • Clinical Data Hub (elluminate®) Review, aggregate, analyze and curate data • Clinical Data Repository Data from the CDR is accessed from statistical computing environment for analysis • Enterprise Data Lake An enterprise data lake is being built to include genomics and other real-world data sources
Role of the elluminate Platform In the new architecture, elluminate provides streamlined, governed access to a broad set of clinical data. elluminate will be used for data ingestion, transformation, aggregation, and analysis, enabling insights to advance clinical development. Key components of the elluminate implementation include: • Consume data from the Metadata Repository, Rave and other 3rd party applications • Review, and curate clinical data via elluminate Data Central, Mapper and Analytics • elluminate Analytics used by clinical operations and data management replacing existing operational and clinical analytics built internally • elluminate APIs used to export data into the Enterprise Data Lake ecosystem which is being built internally via external APIS
CASE STUDY
CASE STUDY
Implementation Process eClinical Solutions is providing a set of implementation and training services along with data configuration and mapping for the first set of studies to facilitate the initial implementation, rollout and adoption. These include: • Formal training courses for role-based end user training on Data Central, Mapper and Analytics • Implementation consulting via subject matter experts who align business objectives to the tools and functionality and identify elluminate best practices by role and function • Enablement training for the client team to use Mapper to configure and map data within elluminate for future trials The implementation process is currently underway. New trials plan to begin using the new integrated architecture in the fall of 2019.
LEARN MORE The elluminate® Clinical Data Hub is a cloud based enterprise software platform that makes clinical data acquisition, mapping and analysis easy and intelligent for clinical teams. More than 100 life sciences companies have used the elluminate platform and software enabled services from eClinical Solutions to regain control of their clinical trial data. For more information or to request a demonstration, visit us at www.eclinicalsol.com or email us at info@eclinicalsol.com. US Office 603 West Street Mansfield, MA 02048
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